ODX.L Regulatory News (ODX)

OMEGA DIAGNOSTICS GROUP PLC

("Omega" or the "Company" or the "Group")

Update on progress of UK-Rapid Test Consortium

Significant progress in development with design freeze expected in June

Omega (AIM: ODX), the medical diagnostics company focused on CD4, food intolerance and allergy testing, notes the Press Release issued today by UK Rapid Test Consortium ("UK-RTC") on developing a COVID-19 lateral flow antibody test ("COVID-19 Rapid Test") that can be used by people in their homes.

As announced on 9 April 2020, the Company signed a Memorandum of Understanding ("MOU") with Abingdon Health Limited, BBI Solutions Limited, CIGA Healthcare Limited, in conjunction with the University of Oxford to form the UK-RTC in order to jointly develop and manufacture a COVID-19 Rapid Test as part of the Government's five pillar national testing strategy for COVID-19.

As lead partner of the UK-RTC, Abingdon Health Limited has been developing the COVID-19 Rapid Test and the Company notes the significant progress made to date in such a short period of time. The Company's role as a member of the UK-RTC is unchanged in that it is providing development support where required and will provide volume manufacturing capacity of the COVID-19 Rapid Test once design freeze has been attained by Abingdon Health and they have successfully transferred the manufacturing protocols to the Company.

Omega will provide a further update once design freeze of the COVID-19 Rapid Test has been reached, a key milestone that the consortium hopes will be attained in June.

The UK-RTC Press Release is provided in full at the end of this announcement.

Colin King, CEO of Omega commented: "I am really impressed with the progress Abingdon have made to date with the development in such a short period of time. Everyone is working extremely hard to deliver a high-quality product as soon as possible to help play a part in returning life back to more normal levels in the UK."

The information communicated in this announcement is inside information for the purposes of Article 7 of EU Regulation 596/2014.

Contacts: 

Press Release from UK-RTC (issued on 3 June 2020)

The UK-RTC has made significant progress in developing a COVID-19 lateral flow antibody test that can be used by people in their homes, since its inception 7 weeks ago. In addition, we have also made progress with the regulatory and logistics challenges needed to be overcome to support the Government in deploying the test directly to individuals across the UK.

With regards to the test progress, we are now consistently picking up positive samples across the range, including weak positives, whilst ensuring negative samples are not detected. We have conducted a small-scale study of 66 samples and results suggest the test is performing in line with design requirements. We expect to reach design freeze in June, which will allow us to move onto scale up, verification and validation activities, prior to the test being made available for manufacture.

In parallel with the above activities, we are working with Government and regulatory authorities to ensure proper approval of the test as quickly as possible.

The consortium is working with NHSX to develop a test specific app and digital service that will facilitate use and reading of the test device. This will have the ability to integrate with NHS systems and update records.

Finally, given the scale of the potential demand for the test within the UK, critical planning around supply chain logistics is also well under way, which will ensure a smooth introduction of the test directly to the public.

This is a very complex project that is being completed at extraordinary speed, compared to a normal test development programme, but thanks to the creative and hard work of everyone involved we remain on track to deliver a test to the UK that will make a significant difference to the approach needed to manage Covid-19 infections.